最新形位公差之位置度详解教学讲义PPT.ppt

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1、形位公差之位置度详解一，位置度定义位置度：公差域在以作为对象点的理论上正确位置（下面称为真位置）为中心，并以直径t的圆或球体中的区域。位置度符号及表达：符号常见表达二，位置度示意坐标标注分布圆+夹角2，坐标标注转换注：在平时的工作中，我们习惯直接用x按多少、y按多少来定位一个图形的位置，但是由于位置度的定义是以一直径来表示它的特性，所以我们在将位置度转换成我们常说的x按多少、y按多少时则要求将尺寸控制在安全区以内。安全值怎么算？备注：正弦值（sina）=对边值/斜边值最后此范例中x向、y向公差分

2、别为：35.749+/-0.006，28.949+/-0.0063，分布圆+夹角转换注:此种表达位置度的方式要求必须同时满足分布圆的公差及夹角的公差。最后此范例中最后的公差为：51°+/-0.007°、φ92+/-0.011以上讲述属个人见解，如有不足之处请多多指教。Theend，thankyou！IntegratedSummariesofImmunogenicity:AnFDAReviewer’sWishListDisclaimerViewsexpressedinthispresentati

3、onarepersonal,andreflectiveofmyexperienceasanimmunogenicityreviewerfortheOfficeofBiotechnologyProducts.MyviewsarenotnecessarilyreflectiveofviewsorcurrentpoliciesoftheFDA.The“IntegratedSummaryofImmunogenicity”isoptionalforBLAsFDAmayincludeanISIrecomme

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6、r351(a)and351(k)biologicsatCDERInvolvedinwritingFDAImmunogenicityguidancesImmunogenicityWorkingGroupFDAImmunogenicityGuidancesGuidance(2014):ImmunogenicityAssessmentforTherapeuticProteinProductDiscussesproductandpatientriskfactorsthatmaycontributetoi

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